2024-512217-40-00招募中3 期
An Open-label, Rollover Study of Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib Study
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 6
- 主要终点
- Serious adverse events, treatment-related adverse events, and any AEs leading to treatment discontinuation graded according to NCI-CTCAE v5.0
研究概览
简要总结
To collect long term safety information in patients continuing to receive treatment with futibatinib as monotherapy or in combination with Fulvestrant who participated in a Taiho-sponsored Futibatinib study and who are deriving clinical benefit with no undue risk.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Provide written informed consent.
- •Receiving futibatinib as monotherapy or in combination with fulvestrant in an antecedent futibatinib study and deriving clinical benefit with no undue risk as assessed by the investigator.
- •Women of childbearing potential (WOCBP) must have a negative pregnancy test (urine or serum) within 7 days prior to receiving treatment under this protocol. (Female patients are not considered to be of childbearing potential if they are permanently sterile [hysterectomy, bilateral salpingectomy, or bilateral oophorectomy] or are postmenopausal [no menses for 12 months without an alternative medical cause]). Both males and females of reproductive potential must agree to use effective birth control during study treatment and for a specified time after the last dose of study treatment.
- •Ability to take medications orally (PO) (feeding tube is not permitted).
排除标准
- •Has met any discontinuation criteria within the antecedent futibatinib study.
结局指标
主要结局
Serious adverse events, treatment-related adverse events, and any AEs leading to treatment discontinuation graded according to NCI-CTCAE v5.0
Serious adverse events, treatment-related adverse events, and any AEs leading to treatment discontinuation graded according to NCI-CTCAE v5.0
次要结局
- Not Applicable
研究者
Medical Monitor
Scientific
Taiho Oncology Inc.
研究点 (6)
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